BXNClass II

Stimulator, Nerve, Battery-Powered

21 CFR 868.2775 / Anesthesiology

BXN is the FDA product code for Stimulator, Nerve, Battery-Powered, a class II device type, regulated under 21 CFR 868.2775. As of 2026-09-10, FDA records hold 63 510(k) clearances under this code, the most recent dated 2022-10-16, and 5 recalls.

Classification record

Product code: BXN
Device name: Stimulator, Nerve, Battery-Powered
Regulation: 21 CFR 868.2775
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 63
Ingested recalls: 5

Clearances, product code BXN

By decision year

63 clearances under product code BXN with a decision year between 1976 and 2022, 1986 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code BXN by decision year
Year	Clearances
1976	1
1977	2
1979	3
1981	1
1982	5
1983	1
1984	1
1985	1
1986	9
1987	4
1988	3
1989	6
1991	3
1993	1
1996	1
2001	3
2003	1
2005	1
2006	2
2007	3
2009	2
2010	1
2011	2
2013	1
2014	1
2015	1
2016	1
2017	1
2022	1

Applicants with the most clearances

Product code BXN

Applicants holding the most 510(k) clearances under product code BXN
Applicant	Clearances
Biometer Intl. A/S	6
Xavant Technology (Pty) Ltd	6
Stockert GmbH	4
Life-Tech Intl., Inc.	3
Pajunk GmbH Medizintechnologie	3
Regional Master Corp.	3
C.R. Bard Inc	2
Medtronic, Inc.	2
Neuro Technology	2
Professional Instruments Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order